Tris(triphenylphosphine)rhodium (I) chloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2 May 1988 – 5 May 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted according to OECD guideline No. 405 and EEC guideline 84/449/EEC

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tris(triphenylphosphine)rhodium (I) chloride

EC Number:

238-744-5

EC Name:

Tris(triphenylphosphine)rhodium (I) chloride

Cas Number:

14694-95-2

Molecular formula:

C54H45ClP3Rh

IUPAC Name:

tris(triphenylphosphine)rhodium (I) chloride

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): chlorotris-(triphenylphosphine)-rhodium(I)
- Molecular formula (if other than submission substance): RhCl(PPh3)3
- Substance type: red powder
- Physical state: solid
- Purity: no data
- Composition of test material, percentage of components: 11% Rh
- Lot/batch No.: 6549
- Stability under test conditions: There was no information from the sponsor indicating a limited durability of the test substance.
- Storage condition of test material: room temperature
- Other: insoluble in water, neutral pH

Test animals / tissue source

Species:

rabbit

Strain:

other: White Russian (albino)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: ASTA Pharma AG, D-4800 Bielefeld 14
- Age at study initiation: 4-5 months
- Weight at study initiation: 2.14-2.42 kg
- Housing: 1 animal/cage in stainless steel cages with grating floor
- Diet: ad libitum standard diet, ssniff K “special diet for rabbits” supplied by ssniff Spezialfutter GmbH, D-4770 Soest.
- Water: ad libitum
- Acclimation period: Animals kept 1 day under the test conditions before application of the test material.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-22.5
- Humidity (%): 40-55
- Photoperiod (hrs dark / hrs light): 6 am-6 pm artificial lighting, 6 pm-6 am “natural light-dark-rhythm”

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: No, although left eye of each animal remained untreated

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.07 g

Duration of treatment / exposure:

Single instillation. Eye not rinsed, therefore possibly for 3 days

Observation period (in vivo):

1, 24, 48 and 72 hrs post application

Number of animals or in vitro replicates:

1 male and 2 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done

SCORING SYSTEM: Signs of irritation on the cornea, iris and conjunctiva were assessed quantitatively and qualitatively using the Draize scale and the mean values of the individual grades at examination times 1, 24, 48 and 72 hrs expressed by a corresponding score. The irritation index is the sum of these scores. A corresponding graduation was allocated to this index using a modified method according to Gilman et al. (1983).

Index Ranges Gradation
0 – 10 non-irritant
11 – 25 slightly irritant
26 – 56 moderately irritant
57-110 severely irritant

TOOL USED TO ASSESS SCORE: Cliptrix pencil light (No. 645) supplied by Varta, D-3000 Hanover.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hrs

Score:

3

Max. score:

110

Reversibility:

fully reversible within: 48 hrs

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hrs

Score:

0

Max. score:

10

Reversibility:

other: Not applicable

Remarks on result:

other: No effects were reported on the iris.

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hrs

Score:

0

Max. score:

80

Reversibility:

other: Not applicable

Remarks on result:

other: No effects were reported on the cornea.

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hrs

Score:

3

Max. score:

20

Reversibility:

fully reversible within: 48 hrs

Irritant / corrosive response data:

Examination of the conjunctiva revealed hyperemia (grade 1) or diffuse crimson redness (grade 2) during the first day of observation in all 3 animals. One animal also had slight swelling (grade 1). The findings were completely reversible and had disappeared 48 hrs after application. There was no evidence of any irritant effects on the cornea nor iris, nor any effects in the untreated eye.

Other effects:

During the first day of observation, discharge with moistening of lids and hairs or considerable areas around the eye was recorded. There were no systemic toxic effects and the general condition of the animals was undisturbed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a guideline eye irritation study, conducted to GLP, chlorotris-(triphenylphosphine)-rhodium(I) (0.07 g) produced a primary irritation index of 3 (out of 110) following application into the conjunctival sac of the right eye of three rabbits.

Executive summary:

In an OECD Test Guideline 405 study, conducted to GLP, chlorotris-(triphenylphosphine)-rhodium(I) (0.07 g) was instilled into the conjunctival sac of the right eye of one male and 2 female White Russian rabbits and both lids were briefly closed by gentle finger pressure. The other eye remained untreated and acted as the control. The treated eye was then assessed, quantitatively and qualitatively, for signs of irritation on the cornea, iris and conjunctiva using the Draize scale 1, 24, 48 and 72 hrs post application.

 

The sum of the scores at observation times 1, 24, 48 and 72 hrs was combined to give an irritation index of 3 (out of a possible 110). Slight signs of irritation in the conjunctivae (including hyperaemia, diffuse crimson redness and swelling) seen during the first day of observation, were fully reversible within 48 hours. No effects were seen in the iris or cornea. Chlorotris-(triphenylphosphine)-rhodium(I) was, therefore, classified as non-irritant in this test system. No corrosive effects or systemic toxicity were observed.

 

Based on the results of this study, no classification for eye irritation is required according to EU CLP criteria (EC 1272/2008).